MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DL POLYURETHANE CATH RADIOLOGY 135CM NITINOLGW; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refq2182 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "picc was placed by ir under fluoro on 6/20.Backflow of fluid from purple lumen to red lumen was noticed on 6/20.Picc was removed and new picc placed over wire exchange on 6/20".
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of an intraluminal leak was confirmed and appears to be related to the manufacturing process.The product returned for evaluation was a 5fr d/l powerpicc catheter.Dried reddish residual material was seen throughout the sample and adhesive residue was noted on the extension legs, indicating usage of the device.The catheter shaft contained a curved shape memory with the apex of the curves being near the 0cm, 9cm and 29cm depth markings.The catheter outer diameter, lumen widths, lumen heights, and wall thicknesses of the tubing were measured and confirmed to meet the device specifications.When an attempt was made to flush the catheter, both lumens were patent to infusion.No leaks were seen emanating from the sample and no water was observed emanating from the adjacent lumen when the catheter was flushed.The distal end of the catheter was then clamped with atraumatic hemostats and the catheter was flushed against the occlusion, creating a positive pressure within the device.No leaks were detected when the red lumen was flushed.However, when the purple lumen was flushed against the occlusion, fluid was seen emanating from the red luer adaptor, indicating an intraluminal leak.The hemostats were moved to just distal of the bifurcation and again, the sample was tested.Intraluminal communication continued when tested, indicating that the leak was likely within the bifurcation of the device.The bifurcation was split longitudinally by the investigator to allow for visual observation of the fluid track inside the bifurcation.The molding between the extension legs and catheter tubing appeared complete and unremarkable.However, a small longitudinal split was noted in the catheter shaft material within the molded bifurcation.The split was located 0.57¿ from the proximal end of the bifurcation.The split was 0.0357¿ long with a finely granular texture on the surface of the split edges.The characteristics and location of the split were consistent with damage caused during the over-molding process.The end-item manufacturing facility has been notified of this complaint.Bd is working closely with manufacturing to prevent recurrence of the reported event.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported "picc was placed by ir under fluoro on 6/20.Backflow of fluid from purple lumen to red lumen was noticed on 6/20.Picc was removed and new picc placed over wire exchange on 6/20".

• Brand Name: POWERPICC 5F DL POLYURETHANE CATH RADIOLOGY 135CM NITINOLGW
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12350878
• Report Number: 3006260740-2021-03434
• Device Sequence Number: 14339974
• Product Code: LJS
• UDI-Device Identifier: 00801741027949
• UDI-Public: (01)00801741027949
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3275335
• Device Lot Number: REFQ2182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 10/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other